eicosapentaenoic acid ethyl ester; ethyl icosapentate (Vascepa)
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Indications
- adjunct therapy for severe hypertriglyceridemia
- serum triglyceride > 500 mg/dL, FDA approved July 26, 2012
- patients with both diabetes & atherosclerotic cardiovascular disease or other cardiac risk factors + elevated triglycerides & controlled LDL cholesterol while taking statins[7]
- FDA allows off-label use to lower serum triglycerides < 500 mg/dL
- may reduce major cardiovascular events[5]
- FDA-approved for cardiovascular risk reduction[8]
- provides additional cardiovascular risk reduction beyond statins in patients with serum triglycerides 135-500 mg/dL[6]*
- 25% relative cardiovascular risk reduction in patients > 50 years with diabetes mellitus, hypertriglyceridemia & at least one additional cardiovascular risk factor (REDUCE-IT)[10] (compare with ref[9])
- it seems that the mineral oil placebo used in the REDUCE-IT trial increased cardiovascular risk & icosapent ethyl (Vascepa) had little effect[11]
* achieving higher EPA plasma levels through pharmacological means does not reduce adverse cardiovascular outcomes in patients taking statins with elevated serum triglycerides[9]
Dosage
* swallow VASCEPA capsules whole
* Do not break open, crush, dissolve, or chew VASCEPA
Pharmacokinetics
- hydrolyzed to 5,8,11,14,17-eicosapentaenoic acid (EPA)
- 1/2life of EPA is 89 hours[3]
Adverse effects
- arthralgias
- may cause atrial fibrillation[12]
Mechanism of action
- converted to eicosapentaenoic acid
- reduces serum triglycerides (up to 27%)
- does not increase in LDL cholesterol
- does not decrease HDL cholesterol
- increases cholesterol & triglyceride in skeletal muscle
More general terms
References
- ↑ Amarin Announces FDA Approval of Vascepa(TM) (icosapent ethyl) Capsules for the Reduction of Triglyceride Levels in Adult Patients With Severe Hypertriglyceridemia http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=696027
- ↑ Prescriber's Letter 20(1): 2013 CHART: Non-Statin Lipid-Lowering Agents Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=290122&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 3.0 3.1 PubChem: 9831415
- ↑ Orciari Herman A, Sadoughi S, Saitz R FDA Allows Omega-3 Company to Market Product for Unapproved Use. Physician's First Watch, March 10, 2016 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
- ↑ 5.0 5.1 Gever J Vascepa Prevents Major Cardiovascular Events, Says Manufacturer. Big win for proprietary fish-oil product. MedPage Today. September 24, 2018 https://www.medpagetoday.com/cardiology/prevention/75271
ClinicalTrials.gov. April 2, 2018 A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT) https://clinicaltrials.gov/ct2/show/NCT01492361 - ↑ 6.0 6.1 Bhatt DL, Steg PG, Miller M et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med 2018 Nov 10; PMID: https://www.ncbi.nlm.nih.gov/pubmed/30415628 https://www.nejm.org/doi/10.1056/NEJMoa1812792
- ↑ 7.0 7.1 American Diabetes Association Issues Critical Updates to the 2019 Standards of Medical Care in Diabetes. News Release. March 27, 2019 http://www.diabetes.org/newsroom/press-releases/2019/ada-issues-critical-updates-to-2019-standards-of-care.html
- ↑ 8.0 8.1 Styles S FDA Approves Amarin's Vascepa for Cardiovascular Risk Reduction. Medscape. Dec 13, 2019. https://www.medscape.com/viewarticle/922673
FDA News Release. Dec 13, 2019 FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups. https://www.fda.gov/news-events/press-announcements/fda-approves-use-drug-reduce-risk-cardiovascular-events-certain-adult-patient-groups - ↑ 9.0 9.1 9.2 Nissen SE, Lincoff M, Wolski K et al Association Between Achieved omega-3 Fatty Acid Levels and Major Adverse Cardiovascular Outcomes in Patients With High Cardiovascular Risk. A Secondary Analysis of the STRENGTH Trial. JAMA Cardiol. Published online May 16, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/33993205 https://jamanetwork.com/journals/jamacardiology/fullarticle/2779978
- ↑ 10.0 10.1 Medical Knowledge Self Assessment Program (MKSAP) 19. American College of Physicians, Philadelphia 2021
Bhatt DL et al Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22 PMID: https://www.ncbi.nlm.nih.gov/pubmed/30415628 Clinical Trial. https://www.nejm.org/doi/10.1056/NEJMoa1812792 - ↑ 11.0 11.1 11.2 Ridker PM et al. Effects of randomized treatment with icosapent ethyl and a mineral oil comparator on interleukin-1beta, interleukin-6, C-reactive protein, oxidized low-density lipoprotein cholesterol, homocysteine, lipoprotein(a), and lipoprotein-associated phospholipase A2: A REDUCE-IT biomarker substudy. Circulation 2022 Jun 28; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/35762321 https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.059410
Harrington RA. Trials and tribulations of randomized clinical trials. Circulation 2022 Jul 1; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/35775415 https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.060649 - ↑ 12.0 12.1 van den Heuvel M EMA Warns That Omega-3-Acid Ethyl Esters May Cause AF. Medscape. Oct 13, 2023 https://www.medscape.com/viewarticle/997348
- ↑ Precribing Information. icosapent ethyl (Vascepa) http://www.vascepa.com/vascepa-pi-ppi-%28clean%29-P00120G-6-15.pdf